When a dangerous or defective product is put on the market, a recall is usually issued to remove it. This can be done voluntarily by the manufacturer or seller, or it can be mandated by a government agency such as the FDA, CPSC and FSIS.
We reported on three recent product recalls that carry the risk of burns and fire. These products were available in stores as well as through online retailers. Tap or click here for details and instructions on dealing with these items if you have any of them.
A seller can be compelled to remove a product even if there is no recall. Amazon has pulled certain supplements that could have harmful ingredients after being contacted about them by the FDA.
In December 2020, the Food and Drug Administration issued a warning to consumers regarding “nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk.”
The products were purchased by the FDA from Amazon and eBay from December 2019 to February 2020. Test results revealed that the products contain “active pharmaceutical ingredients” that were not listed on their labels, which violates federal law. These ingredients can carry serious side effects and interfere with medications or dietary supplements consumers are taking.
All 26 of the products purchased on Amazon and 20 of the 25 products obtained through eBay contained unlisted active pharmaceutical ingredients. These included sildenafil, tadalafil, vardenafil, sibutramine, desmethyl sibutramine, phenolphthalein and/or fluoxetine. Many of these ingredients can be found in FDA-approved prescription drugs, which can only be obtained after seeing a doctor.
Many of the Amazon products are carried an Amazon’s Choice or #1 Best Seller label.
The FDA has been issuing warnings such as these for years but continues to find dangerous products available through online retailers.
In July 2021, the FDA addressed a letter to Amazon CEO Andy Jassy regarding the company’s distribution of dangerous and illegal products. The letter recaps the December 2020 warning and the testing that was done.
Even though Amazon said it had “restricted” the sale of the 26 sexual enhancement products, along with their sellers, the FDA was able to purchase one of them in January 2021. In March, the FDA purchases two new sexual enhancement products from Amazon that contained undeclared ingredients.
These products are labeled and described as dietary supplements, but they do not meet the FDA’s definition of “dietary supplement.”
Amazon has 15 working days from the date of receipt of the letter to respond to the FDA. The letter must contain a detailed plan to address the violations. Amazon can not “introduce, deliver, or cause the introduction or delivery” of unapproved and mislabeled new drugs or any with undeclared ingredients.
Amazon can also fight the accusation with supporting information.
Here is the list of 29 dangerous products as found at the bottom of the FDA letter:
- Imperial Gold 2000
- Hot Rod
- PremierZen Platinum 5000
- PremierZen Black 5000
- Imperial Extreme 2000
- Burro Primavera 60000
- Thumbs Up 7 Blue 69K
- Kopi Jantan Tradisional Natural Herbs Coffee
- Thumbs Up 7 Red 70K
- OrgaZen Premium
- Shogun-X Platinum 7000
- Ginseng Power 5000
- PremierZen Extreme 3000
- Shogun-X Black
- Original White Dragon
- Triple SupremeZen Plus 3500
- Triple SupremeZen Extreme 3500
- Triple SupremeZen Gold 3500
- Thumbs Up 7 (Black) 25K
- Krazy Night
- Thumbs Up 7 White 11K
- Imperial Platnum 2000
- 3 KO Gold XT
- Rock Steady 72 Hours
- 69MODE Blue 69
- Red Spartan 3000
- Adam’s Secret Extra Strength 1500
- Adam’s Secret Extra Strength 2000
- Miss Slim
The FDA is urging anyone taking the supplements on this list to stop immediately.